Table 3.
Summary of ipilimumab clinical trials in CRPC
| Study | Phase/setting | Design [Primary endpoint] | Site(s) |
|---|---|---|---|
| NCT01057810 | Phase 3 1st line CRPC | Ipilimumab (10 mg/kg q3w × 4 → q12w) versus placebo [OS] | International |
| NCT00861614 | Phase 3 2nd+ line CRPC | Single-dose XRT → randomization to ipilimumab (10 mg/kg q3w × 4 → q12w) versus placebo [OS] | International |
| NCT01194271 | Phase 2 Neoadjuvant | Ipilimumab (10 mg/kg q3w × 3) + hormone ablation → radical prostatectomy [safety] | US |
| NCT01377389 | Phase 2 1st line HS | Ipilimumab (10 mg/kg q4w × 4) + leuprolide acetate (7.5 mg/month × 8) [response by PSA] | US |
| NCT00170157 | Phase 2 1st line HS | Ipilimumab (3 mg/kg once) + leuprolide (7.5 mg/month × 3) + bicalutamide (50 mg/day × 3 months) versus leuprolide + bicalutamide alone [PFS] | US |
| NCT01530984 | Phase 2 1st line CRPC | Ipilimumab (10 mg/kg q4w × 6) + GM-CSF (250 mcg/m2 days 1–14 × 6) versus ipilimumab alone [response by PSA] | US |
| NCT00064129 | Phase 1 1st line CRPC | Ipilimumab (0.5–3 mg/kg q4w) + GM-CSF (250 mcg/m2 days 1–14 × 4) [MTD, safety, reduction in PSA] | US |
CRPC, castration-resistant prostate cancer; GM-CSF, granulocyte macrophage colony-stimulating growth factor; HS, hormone sensitive; MTD, maximum-tolerated dose; OS, overall survival; PFS, progression-free survival; PSA, prostate-specific antigen; qXw, every X weeks; XRT, radiotherapy.